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18-03-2016, 07:56 PM
New list of 1200 drugs to be banned in India by regulator
Earlier this week, Indian Health Ministry took a significant step by banning more than 350 fixed-dose combinations (FDCs) in the country for safety reasons.
According to a report in Hindustan Times, recently a new list of 1,200 fixed-dose combinations (FDCs) has been sent for probe by Drug Controller General of India (DGCI) to the panel that banned about 350 drugs last week.
Fixed dose combination or FDC drugs contain two or more active pharmaceutical ingredients in fixed proportions in a single pill and also contain codeine which causes lethal damage to brain and psyche.
So far about 6,600 FDCs has been reviewed by the Kokate Committee and have classified them under four categories of irrational, require further deliberations, rational and require additional data generation, as reported.
“Under the irrational category, there were 963 FDCs, out of which 350 have been announced, and the list has been dismantled. We have moved to the ‘require further deliberations’ category, where the final list is expected to come in six months,” an official at the Central Drugs Standard Control Organisation (CDSCO) was quoted as saying in the report.
The DGCI has now submitted the “B” list to the Kokate committee. Out of the 1,200 FDCs mentioned in the list, 8-10%, i.e. around 120 drugs, would fall under the banned category, a senior DGCI official said.
“As per estimate, each FDC has at least 5 to 10 brands in the market, which means around 1,200 more drugs are likely to be banned,” the official at CDSCO added.
“We are not against any product or brand. We are only siphoning off the irrational combinations,” said CK Kokate, chairman of the committee formed by the government to reviewed FDCs in the HT report.
According to a report in Hindustan Times, recently a new list of 1,200 fixed-dose combinations (FDCs) has been sent for probe by Drug Controller General of India (DGCI) to the panel that banned about 350 drugs last week.
Fixed dose combination or FDC drugs contain two or more active pharmaceutical ingredients in fixed proportions in a single pill and also contain codeine which causes lethal damage to brain and psyche.
So far about 6,600 FDCs has been reviewed by the Kokate Committee and have classified them under four categories of irrational, require further deliberations, rational and require additional data generation, as reported.
“Under the irrational category, there were 963 FDCs, out of which 350 have been announced, and the list has been dismantled. We have moved to the ‘require further deliberations’ category, where the final list is expected to come in six months,” an official at the Central Drugs Standard Control Organisation (CDSCO) was quoted as saying in the report.
The DGCI has now submitted the “B” list to the Kokate committee. Out of the 1,200 FDCs mentioned in the list, 8-10%, i.e. around 120 drugs, would fall under the banned category, a senior DGCI official said.
“As per estimate, each FDC has at least 5 to 10 brands in the market, which means around 1,200 more drugs are likely to be banned,” the official at CDSCO added.
“We are not against any product or brand. We are only siphoning off the irrational combinations,” said CK Kokate, chairman of the committee formed by the government to reviewed FDCs in the HT report.
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